Back to resultsA Study to Assess the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-048)
Primary Purpose
Urinary Tract Infection
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ertapenem sodium
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Tract Infection
Eligibility Criteria
Inclusion Criteria:
- Patient has a complicated urinary tract infection
- Patient has acute pyelonephritis with fever, flank pain, pus in the urine, and positive urine culture
- Patient is indian and 18 years of age or greater.
Exclusion Criteria:
- Patient had a kidney transplant
- Patient had been given antibiotic therapy for condition
- Patient had poor liver function
- Patient has complete obstruction of urinary tract
- Patient has history of serious allergy to antibiotics and multivitamins
- Patient is pregnant
- Patient not likely to respond to 10 to 14 days of antibiotic therapy
- Patient not likely to survive 4 week study period
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Arm 1: ertapenem sodium
Outcomes
Primary Outcome Measures
Safety and tolerability
Secondary Outcome Measures
Compare signs and symptoms of urinary tract infections at 14 days after treatment compared with signs and symptoms before treatment
Full Information
NCT ID
NCT00379951
First Posted
September 22, 2006
Last Updated
February 16, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00379951
Brief Title
A Study to Assess the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-048)
Official Title
A Prospective, Multicenter, Noncomparative, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem sodium as initial therapy for the treatment of complicated urinary tract infections, including pyelonephritis in indian adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Arm 1: ertapenem sodium
Intervention Type
Drug
Intervention Name(s)
ertapenem sodium
Other Intervention Name(s)
MK0826, Invanz
Intervention Description
ertapenem sodium as a single dose of 1gm I.V. was infused over a 30 min interval for a minimum of 3 days to a maximum of 14 days.
Primary Outcome Measure Information:
Title
Safety and tolerability
Time Frame
14 Days
Secondary Outcome Measure Information:
Title
Compare signs and symptoms of urinary tract infections at 14 days after treatment compared with signs and symptoms before treatment
Time Frame
14 days after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient has a complicated urinary tract infection
Patient has acute pyelonephritis with fever, flank pain, pus in the urine, and positive urine culture
Patient is indian and 18 years of age or greater.
Exclusion Criteria:
Patient had a kidney transplant
Patient had been given antibiotic therapy for condition
Patient had poor liver function
Patient has complete obstruction of urinary tract
Patient has history of serious allergy to antibiotics and multivitamins
Patient is pregnant
Patient not likely to respond to 10 to 14 days of antibiotic therapy
Patient not likely to survive 4 week study period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
A Study to Assess the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-048)
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